Thrombus Aspiration for OcLuded Coronary Artery Enhanced With Distal Injection Of Abciximab — TOLEDO1  

Myocardial Infarction Clinical Trial

Official title: Phase 4 Study of Primary Angioplasty Combined Distal Injection of Abciximab to Thrombus and Aspiration With Catheter

Status Recruiting

Clinical Trial Summary

Aims: (to prove that) The distal injection of IIb IIIa platelet receptor blocker to the thrombus occlusion is better than normal injection during primary percutaneous intervention (PCI) for the treatment of acute myocardial infarction. Using this modification of injection method the investigators can achieve less microvascular damage and a reduction of the infarct size with a significant improvement of the outcome at six months.

Clinical Trial Description

There are some evidence about the utilization of aspiration catheter (Indication class IIb with level of evidence B in European Guidelines) and intravenous abciximab (indication Class IIa an level of evidence A in European Guidelines) in primary PTCA. Direct intracoronary injection of abciximab get smaller infarct size than intravenous injection. The hypothesis of our study are that direct distal injection of abciximab by aspiration catheter will be better than proximal intracoronary injection with reduction in infarct size and microvascular damage quantified by Magnetic resonance (MR) and 6 months mortality. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myocardial Infarction
• Occlusive Thrombus

• NCT number: NCT01383785
• Study type: Interventional
• Source: Hospital Virgen de la Salud
• Contact: Jose Moreu, MD,PhD
• Phone: +34 925 269 188
• Email: jmoreu@sescam.jccm.es
• Status: Recruiting
• Phase: Phase 4
• Start date: November 2009
• Completion date: December 2012